FDAFDA recall Z-2927-2026 · Aug 19, 2026
Remel Europe Ltd.: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL recall
Recall found
Product
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Reason for recall
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI/DI 05056080501161, Lot Numbers: 6214791, exp. 18/03/2025; 6175327, exp. 04/12/2027; 6148809, exp. 30/09/2027; 6002010, exp. 31/07/2027.
- Quantity
- 26 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Remel Europe Ltd., Dartford
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-17
Source: openFDA enforcement record Z-2927-2026 · search recall number Z-2927-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.